Kusum Healthcare General Manager Quality Assurance Interview Questions and Answers

Q1. Tell me about yourself.
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Q2. What are your strengths and weaknesses?
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Q1. TGA Guidelines Sterilization QMS
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Q2. All mentioned in CV
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English and Maths and logical reasoning

Q1. Why you want to change the Organisation
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Q2. Why we'll select you
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Q1. Which products you dealt with, MOA of them
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Q2. Why you want this profile
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Q3. How you have prepared yourself for the position
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Q1. Your salary expectation
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Q1. Questions about your profile mentioned in your resume
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Sorting write code on ticket booking with re arrange of seat

Q1. Tell me about change Control? And give me One Example?
Ans. 
Change control is a process used to manage and document changes to a system or process.
• Change control ensures that changes are properly reviewed, approved, and implemented.

• It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

• Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing...read more
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Q2. What are the ypes of Process validation?
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Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.
• There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

• Prospective validation is conducted before the process is put into routine use.

• Concurrent validation is performed during routine production.

• Retrosp...read more
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Q3. How you are doing Audit trail?
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Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.
• Audit trail is created by recording all actions, events, and transactions that occur within a system.

• It helps in ensuring accountability, traceability, and compliance with regulations.

• Audit trail can be established through the use of logs, timestamps, and version control.

• It is important to capture relevant infor...read more
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Q4. Asking about APQR
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Q5. Are you interested in Microbiology analytical review?
Ans. 
Yes, I am interested in Microbiology analytical review.
• I have a strong background in microbiology and enjoy analyzing data in this field.

• I have experience conducting microbiological tests and interpreting the results.

• I am familiar with various microbiological techniques and methodologies.

• I am interested in staying updated with the latest advancements in microbiology research.

• I believe that my knowledge and skills in mi...read more
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Q1. Purified water specification?
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Purified water specification refers to the set of requirements and standards that purified water must meet.
• Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

• It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

• The pH level of purified water should be within a specific range, typica...read more
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Q2. Purified water specification of Microbal
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The purified water specification for microbial quality assurance.
• Microbial specification for purified water is crucial to ensure its safety and suitability for use.

• The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

• Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

• The specification...read more
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Q3. USP chapters of Microbial tesing of API and water
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Q4. Growth Pramotion tests
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Q5. Horizontal Autoclave validation
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Q6. Types of validation
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Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.
• Functional Validation: Ensuring that the system meets the functional requirements.

• Performance Validation: Verifying that the system performs as expected under different load conditions.

• Security Validation: Checking the system for vulnerabilities and ensur...read more
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Q1. Tell me about your self
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Q2. Are you willing to shift Vizag
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Q3. Salary discussion
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Q1. Can you provide a brief overview of your profile and past experience?
Ans. 
Experienced Senior Manager with a strong background in project management, team leadership, and strategic planning across various industries.
• Over 10 years of experience in project management, successfully leading cross-functional teams to deliver projects on time and within budget.

• Led a team of 15 in a software development project that increased efficiency by 30%, resulting in significant cost savings for the company.

• I...read more
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Q2. What is the current status of project execution, and what is the estimated cost of the project you are managing?
Ans. 
The project is on track with a budget of $1.5 million, focusing on timely delivery and quality outcomes.
• Current status: 75% completed, with major milestones achieved on schedule.

• Estimated cost: $1.5 million, with 60% of the budget utilized so far.

• Key challenges: Resource allocation and supply chain delays, mitigated by proactive planning.

• Example: Implemented agile methodologies to enhance team collaboration and efficie
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Q3. What is the cost of the built-up area for various structures such as RCC tanks, PEB buildings, and clean rooms?
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Q4. What new technologies are being utilized in the completion of Fastrack projects?
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Fastrack projects leverage advanced technologies like AI, IoT, and cloud computing for enhanced efficiency and speed.
• Artificial Intelligence (AI) for predictive analytics and project management.

• Internet of Things (IoT) for real-time monitoring of project resources.

• Cloud computing for collaborative work and data storage.

• Building Information Modeling (BIM) for improved design and construction processes.

• Blockchain technol...read more
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Q5. Do you have any knowledge of clean technologies and concepts within the pharmaceutical industry?
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Q6. What is the importance of safety systems and adherence in the workplace?
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Safety systems ensure a secure workplace, reducing risks and promoting employee well-being and productivity.
• Prevention of accidents: Implementing safety protocols can significantly reduce workplace injuries, such as using proper lifting techniques to avoid back injuries.

• Legal compliance: Adhering to safety regulations helps organizations avoid legal penalties and lawsuits, ensuring they meet OSHA standards.

• Employee mor...read more
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Q7. What are the strategies for implementing cost-saving measures in construction project execution?
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Implementing cost-saving measures in construction requires strategic planning, efficient resource management, and innovative practices.
• Conduct thorough project planning to identify potential cost overruns early.

• Utilize value engineering to optimize project design and materials without compromising quality.

• Implement lean construction techniques to minimize waste and improve efficiency.

• Negotiate bulk purchasing agreement...read more
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Q8. How do you ensure quality monitoring during project execution?
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I implement structured quality monitoring through defined metrics, regular reviews, and stakeholder engagement during project execution.
• Establish clear quality metrics at the project's outset, such as defect rates and customer satisfaction scores.

• Conduct regular quality audits and reviews to assess compliance with standards, like bi-weekly project check-ins.

• Utilize feedback loops from stakeholders to identify quality i...read more
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Q9. What is the largest team size you have managed to date?
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I have managed teams of up to 50 members, focusing on collaboration and performance to achieve project goals.
• Led a cross-functional team of 50 during a major product launch, coordinating efforts across marketing, development, and sales.

• Implemented regular team meetings and feedback sessions to ensure alignment and address challenges promptly.

• Utilized project management tools to track progress and foster communication a...read more
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Q10. What is the process for conducting a technical evaluation and comparison of contract bids for vendor finalization?
Ans. 
A structured approach to evaluate and compare vendor bids for informed decision-making.
• Define evaluation criteria: Establish clear criteria such as cost, quality, delivery time, and compliance with specifications.

• Create a scoring system: Use a weighted scoring model to quantify each bid based on the defined criteria.

• Conduct technical reviews: Assemble a cross-functional team to review the technical aspects of each bid,...read more
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